CTRI/2019/06/019535进行中（未招募）4 期
Post-Marketing Phase 4 Study to Evaluate Safety, Tolerability, and Efficacy of Kyprolis (Carfilzomib) in Indian Patients with Relapsed or Refractory Multiple Myeloma: A Prsopective, Open-Label, Non-Comparative, Multicentre Study
Amgen Technology Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •The age limits are being captured as above for the purpose of this CTRI application.
排除标准
- •1. Waldenström macroglobulinemia
- •2. Plasma cell leukemia
- •3. POEMS syndrome
- •4. Myelodysplastic syndrome
- •5. Primary amyloidosis
- •6. History of other malignancy within the past 5 years, with the following exception[s]:
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- •Adequately treated cervical carcinoma in situ without evidence of disease.
- •Adequately treated breast ductal carcinoma in site without evidence of disease.
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer.
- •Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
- •7. Known immediate or delayed hypersensitivity to Captisol
- •8. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs
- •9. Intolerance to hydration
- •10. Active congestive heart failure (NYHA Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant ECHO abnormalities, screening ECG with corrected QTc of >470 msec, pericardial disease, or myocardial infarction within 4 months prior to enrolment
- •11. Infiltrative pulmonary disease and/or known pulmonary hypertension
- •12.Active infection within 14 days prior to enrolment
- •13. Pleural effusions requiring thoracentesis within 14 days prior to enrolment
- •14. Ascites requiring paracentesis within 14 days prior to enrolment
- •15. Uncontrolled hypertension
- •16. Known HIV infection, hepatitis C infection, or hepatitis B infection
- •17. Ongoing graft-versus-host disease
- •18. Subject with grade 3 or worse neuropathy within 14 days prior to enrolment
- •19. Antitumor therapy or investigational agent within 28 days before enrolment or not recovered from any acute toxicity
- •20. Subjects on immunosuppressive therapy for graft versus host disease
- •21. Glucocorticoid therapy within 14 days before first dose that exceeds cumulative dose of 160mg of dexamethasone or equivalent dose of other corticosteroids
- •22. Focal radiation therapy within 7 days prior to enrolment. Radiation therapy to an extended field involving significant volume of bone marrow within 28 days prior to enrolment
- •23. Autologous stem cell transplant less than 100 days prior to enrolment
- •24. Prior treatment with Kyprolis (carfilzomib)
- •25. Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study
- •27. Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment, during any breaks (interruptions) in the treatment, and for an additional 30 days after last dose of Kyprolis.
- •28. Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment, during any breaks (interruptions) in the treatment, and for an additional 30 days after last dose of Kyprolis.
- •29. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 90 days after the last dose of Kyprolis
- •30. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 90 days
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